Infectious Diseases - Research Publications

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    Point-of-care HCV RNA testing improves hepatitis C testing rates and allows rapid treatment initiation among people who inject drugs attending a medically supervised injecting facility.
    MacIsaac, MB ; Whitton, B ; Anderson, J ; Cogger, S ; Vella-Horne, D ; Penn, M ; Weeks, A ; Elmore, K ; Pemberton, D ; Winter, RJ ; Papaluca, T ; Howell, J ; Hellard, M ; Stoové, M ; Wilson, D ; Pedrana, A ; Doyle, JS ; Clark, N ; Holmes, JA ; Thompson, AJ (Elsevier BV, 2024-03)
    BACKGROUND: To achieve hepatitis C virus (HCV) elimination targets, simplified care engaging people who inject drugs is required. We evaluated whether fingerstick HCV RNA point-of-care testing (PoCT) increased the proportion of clients attending a supervised injecting facility who were tested for hepatitis C. METHODS: Prospective single-arm study with recruitment between 9 November 2020 and 28 January 2021 and follow-up to 31 July 2021. Clients attending the supervised injecting facility were offered HCV RNA testing using the Xpert® HCV Viral Load Fingerstick (Cepheid, Sunnyvale, CA) PoCT. Participants with a positive HCV RNA test were prescribed direct acting antiviral (DAA) therapy. The primary endpoint was the proportion of clients who engaged in HCV RNA PoCT, compared to a historical comparator group when venepuncture-based hepatitis C testing was standard of care. RESULTS: Among 1618 clients who attended the supervised injecting facility during the study period, 228 (14%) engaged in PoCT. This was significantly higher than that observed in the historical comparator group (61/1,775, 3%; p < 0.001). Sixty-five (28%) participants were HCV RNA positive, with 40/65 (62%) receiving their result on the same day as testing. Sixty-one (94%) HCV RNA positive participants were commenced on DAA therapy; 14/61 (23%) started treatment on the same day as diagnosis. There was no difference in the proportion of HCV RNA positive participants commenced on treatment with DAA therapy when compared to the historical comparator group (61/65, 94% vs 22/26, 85%; p = 0.153). However, the median time to treatment initiation was significantly shorter in the PoCT cohort (2 days (IQR 1-20) vs 41 days (IQR 22-76), p < 0.001). Among participants who commenced treatment and had complete follow-up data available, 27/36 (75%) achieved hepatitis C cure. CONCLUSIONS: HCV RNA PoCT led to a significantly higher proportion of clients attending a supervised injecting facility engaging in hepatitis C testing, whilst also reducing the time to treatment initiation.
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    The impact of point-of-care hepatitis C testing in needle and syringe exchange programs on linkage to care and treatment uptake among people who inject drugs: An Australian pilot study
    Howell, J ; Traeger, MW ; Williams, B ; Layton, C ; Doyle, JS ; Latham, N ; Draper, B ; Bramwell, F ; Membrey, D ; McPherson, M ; Roney, J ; Stoove, M ; Thompson, AJ ; Hellard, ME ; Pedrana, A (WILEY, 2022-05)
    Point-of-care (POC) diagnostics overcome barriers to conventional hepatitis C (HCV) testing in people who inject drugs. This study assessed impact on hepatitis C treatment uptake of POC HCV testing in needle and syringe exchange programs (NSPs). Rapid EC was a single-arm interventional pilot study of HCV POC testing conducted in three inner-city community clinics with NSPs. Twelve months after the POC testing, a retrospective medical record and Pharmaceutical Benefits Scheme audit was performed to determine the number of HCV RNA-positive participants who were prescribed HCV treatment. 70 HCV RNA-positive Rapid EC study participants were included. 44 (63%) were prescribed DAAs; 26 (59%) completed treatment and 15 (34%) had SVR testing, all of whom were cured. Age ≥ 40 years (aOR 3.45, 95% CI 1.10-11.05, p = .03) and secondary school education (aOR 5.8, 95% CI 1.54-21.80, p = .009) had higher likelihood of being prescribed DAAs, whereas homelessness was inversely associated with prescription of DAAs (aOR 0.30, 95% CI 0.09-1.04, p = .057). Median time to receive a DAA script from date of diagnosis was seven days (IQR 0 to 14 days), and time to filling the DAA prescription was 2 days (IQR 0-12 days). In conclusion, provision of POC testing through NSPs was effective for linking new clients to HCV treatment and reduced the time to treatment. Further studies are needed to define the most cost-effective use of POC testing in models of care for people who inject drugs to increase HCV treatment uptake.
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    Real-world monitoring progress towards the elimination of hepatitis C virus in Australia using sentinel surveillance of primary care clinics; an ecological study of hepatitis C virus antibody tests from 2009 to 2019 (vol 150, E7, 2022)
    Lee Wilkinson, A ; Pedrana, A ; Traeger, MW ; Asselin, J ; El-Hayek, C ; Nguyen, L ; Polkinghorne, V ; Doyle, JS ; Thompson, AJ ; Howell, J ; Scott, N ; Dimech, W ; Guy, R ; Hellard, M ; Stoove, M (CAMBRIDGE UNIV PRESS, 2022-03-04)
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    Eliminating hepatitis C in Australia: a novel model of hepatitis C testing and treatment for people who inject drugs at a medically supervised injecting facility
    MacIsaac, MB ; Whitton, B ; Hubble, A ; Cogger, S ; Penn, M ; Weeks, A ; Elmore, K ; Pemberton, D ; Anderson, J ; Howard, R ; McKeever, U ; Papaluca, T ; Hellard, ME ; Stoove, M ; Wilson, D ; Pedrana, A ; Doyle, J ; Clark, N ; Holmes, J ; Thompson, AJ (WILEY, 2023-04-03)
    OBJECTIVE: To evaluate the feasibility of testing and treating people who inject drugs at a supervised injecting facility for hepatitis C virus (HCV) infection. DESIGN: Retrospective cohort study. SETTING, PARTICIPANTS: People who inject drugs who attended the Melbourne supervised injecting facility, 30 June 2018 - 30 June 2020. MAIN OUTCOME MEASURES: Proportion of people tested for hepatitis C; proportions of people positive for anti-HCV antibody and HCV RNA, and of eligible people prescribed direct-acting antiviral (DAA) treatment; sustained virological response twelve weeks or more after treatment completion. RESULTS: Of 4649 people who attended the supervised injecting facility during 2018-20, 321 were tested for hepatitis C (7%); 279 were anti-HCV antibody-positive (87%), of whom 143 (51%) were also HCV RNA-positive. Sixty-four of 321 had previously been treated for hepatitis C (20%), 21 had clinically identified cirrhosis (7%), eight had hepatitis B infections (2%), and four had human immunodeficiency virus infections (1%). In multivariate analyses, people tested for hepatitis C were more likely than untested clients to report psychiatric illness (adjusted odds ratio [aOR], 9.65; 95% confidence interval [CI], 7.26-12.8), not have a fixed address (aOR, 1.59; 95% CI, 1.18-2.14), and to report significant alcohol use (aOR, 1.57; 95% CI, 1.06-2.32). The median number of injecting facility visits was larger for those tested for hepatitis C (101; interquartile range [IQR], 31-236) than for those not tested (20; IQR, 3-90). DAA treatment was prescribed for 126 of 143 HCV RNA-positive clients (88%); 41 of 54 with complete follow-up data were cured (76%). CONCLUSIONS: People who attend supervised injecting facilities can be tested and treated for hepatitis C on site. Models that provide streamlined, convenient hepatitis C care promote engagement with treatment in a group in which the prevalence of hepatitis C is high.
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    The cost-effectiveness of universal hepatitis B screening for reaching WHO diagnosis targets in Australia by 2030
    Xiao, Y ; Hellard, ME ; Thompson, AJ ; Seaman, C ; Howell, J ; Scott, N (WILEY, 2023-03-06)
    OBJECTIVES: To assess the impact on diagnosis targets, cost, and cost-effectiveness of universal hepatitis B screening in Australia. DESIGN: Markov model simulation of disease and care cascade progression for people with chronic hepatitis B in Australia. SETTING: Three scenarios were compared: 1. no change to current hepatitis B virus (HBV) testing practice; 2. universal screening strategy, with the aim of achieving the WHO diagnosis target by 2030 (90% of people with chronic hepatitis B diagnosed), based on opportunistic (general practitioner-initiated) screening for HBsAg; 3. universal screening strategy, and also ensuring that 50% of people with chronic hepatitis B are receiving appropriate clinical management by 2030. MAIN OUTCOME MEASURES: Projected care cascade for people with chronic hepatitis B, cumulative number of HBV-related deaths, intervention costs, and health utility (quality-adjusted life-years [QALYs] gained during 2020-2030). An incremental cost-effectiveness ratio (ICER) threshold (v scenario 1) of $50 000 per QALY gained was applied. RESULTS: Compared with scenario 1, 80 HBV-related deaths (interquartile range [IQR], 41-127 deaths) were averted during 2020-2030 in scenario 2, 315 HBV-related deaths (IQR, 211-454 deaths) in scenario 3. Scenario 2 cost $84 million (IQR, $41-106 million) more than scenario 1 during 2020-2030 (+8%), yielding an ICER of $104 921 (IQR, $49 587-107 952) per QALY gained. Scenario 3 cost $263 million (IQR, $214-316 million) more than scenario 1 during 2020-2030 (+24%), yielding an ICER of $47 341 (IQR, $32 643-58 200) per QALY gained. Scenario 3 remained cost-effective if the test positivity rate was higher than 0.35% or the additional costs per person tested did not exceed $4.02. CONCLUSIONS: Universal screening for hepatitis B will be cost-effective only if the cost of testing is kept low and people receive appropriate clinical management.
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    Care Navigation Increases Initiation of Hepatitis C Treatment After Release From Prison in a Prospective Randomized Controlled Trial: The C-LINK Study
    Papaluca, T ; Craigie, A ; McDonald, L ; Edwards, A ; Winter, R ; Hoang, A ; Pappas, A ; Waldron, A ; McCoy, K ; Stoove, M ; Doyle, J ; Hellard, M ; Holmes, J ; MacIsaac, M ; Desmond, P ; Iser, D ; Thompson, AJ (OXFORD UNIV PRESS INC, 2022-08-02)
    BACKGROUND: Prison-based hepatitis C treatment is safe and effective; however, many individuals are released untreated due to time or resource constraints. On community re-entry, individuals face a number of immediate competing priorities, and in this context, linkage to hepatitis C care is low. Interventions targeted at improving healthcare continuity after prison release have yielded positive outcomes for other health diagnoses; however, data regarding hepatitis C transitional care are limited. METHODS: We conducted a prospective randomized controlled trial comparing a hepatitis C care navigator intervention with standard of care for individuals released from prison with untreated hepatitis C infection. The primary outcome was prescription of hepatitis C direct-acting antivirals (DAA) within 6 months of release. RESULTS: Forty-six participants were randomized. The median age was 36 years and 59% were male. Ninety percent (n = 36 of 40) had injected drugs within 6 months before incarceration. Twenty-two were randomized to care navigation and 24 were randomized to standard of care. Individuals randomized to the intervention were more likely to commence hepatitis C DAAs within 6 months of release (73%, n = 16 of 22 vs 33% n = 8 of 24, P < .01), and the median time between re-entry and DAA prescription was significantly shorter (21 days [interquartile range {IQR}, 11-42] vs 82 days [IQR, 44-99], P = .049). CONCLUSIONS: Care navigation increased hepatitis C treatment uptake among untreated individuals released from prison. Public policy should support similar models of care to promote treatment in this high-risk population. Such an approach will help achieve hepatitis C elimination as a public health threat.
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    A survey of knowledge, attitudes, barriers and support needs in providing hepatitis B care among GPs practising in Australia
    Xiao, Y ; van Gemert, C ; Howell, J ; Wallace, J ; Richmond, J ; Adamson, E ; Thompson, A ; Hellard, M (BMC, 2022-06-02)
    BACKGROUND: In Australia, only 22% of people with chronic hepatitis B (CHB) are clinically managed; and a national effort is engaging primary care workforce in providing CHB-related care. This study explored CHB-related knowledge, attitudes, barriers and support needs of general practitioners (GPs). METHODS: A survey was sent to a random sample of 1,000 Australian GPs in April- October 2018; 134 of 978 eligible GPs completed the questionnaire (14%). RESULTS: Respondents had high knowledge of at-risk populations (> 79%) and hepatitis B serology (82%), and most saw hepatitis B testing and monitoring as part of their work (95% and 86%, respectively). However, the survey revealed low knowledge, awareness and intention with respect to hepatitis B treatment: 23% correctly understood treatment initiation; 40% were aware that treatment for CHB could be dispensed in the community; 23% agreed that prescribing was part of their work. Lack of time was considered the greatest barrier (38%) and clear guidelines was the most important facilitator to providing care (72%). CONCLUSION: Interventions are needed to generate interest and skills to provide CHB-related care by GPs.
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    Hepatitis B and pregnancy: understanding the experiences of care among pregnant women and recent mothers in metropolitan Melbourne
    Ahad, M ; Wallace, J ; Xiao, Y ; van Gemert, C ; Bennett, G ; Darby, J ; Desmond, P ; Hall, S ; Holmes, J ; Papaluca, T ; Glasgow, S ; Thompson, A ; Hellard, M ; Doyle, J ; Howell, J (BMC, 2022-04-23)
    BACKGROUND: Pregnant women are a priority group for hepatitis B testing. Guideline-based care during antenatal and post-partum periods aims to prevent mother-to-child transmission of hepatitis B virus and lower the risk of liver complications in mothers. This qualitative study explored knowledge of hepatitis B and experiences of hepatitis B related care among pregnant women and mothers. METHODS: Semi-structured interviews were conducted with thirteen women with hepatitis B who were attending antenatal or post-partum hepatitis B care. The interviews were thematically analysed to assess knowledge and understanding of hepatitis B. Participants were recruited from specialist clinics in metropolitan Melbourne between August 2019 and May 2020. RESULTS: Four major themes were identified from interviews: (1) knowledge and understanding of hepatitis B, (2) treatment pathways, (3) accessing hepatitis B related care, and (4) disclosing status to friends. Most participants displayed an understanding of hepatitis B transmission, including mother to child transmission. The main motivator of post-partum attendance was reassurance gained concerning their child's health. Sources of hepatitis B information included doctors, online information and family. Participants identified parents and siblings as sources of support and reported an unwillingness to disclose hepatitis B status to friends. CONCLUSIONS: Women attending antenatal or post-partum care reported having overall positive experiences, particularly regarding reassurance of their child's health, but displayed misconceptions around horizontal transmission. Knowledge gained from these results can contribute to the development of targeted models of care for pregnant women and mothers with young children to ensure their successful linkage to care.
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    Randomised controlled trial of active case management to link hepatitis C notifications to treatment in Tasmania, Australia: a study protocol
    Marukutira, T ; Moore, KP ; Hellard, M ; Richmond, J ; Turner, K ; Pedrana, AE ; Melody, S ; Johnston, FH ; Owen, L ; Van den Boom, W ; Scott, N ; Thompson, A ; Iser, D ; Spelman, T ; Veitch, M ; Stoove, MA ; Doyle, J (BMJ PUBLISHING GROUP, 2022-03)
    INTRODUCTION: By subsidising access to direct acting antivirals (DAAs) for all people living with hepatitis C (HCV) in 2016, Australia is positioned to eliminate HCV as a public health threat. However, uptake of DAAs has declined over recent years and new initiatives are needed to engage people living with HCV in care. Active follow-up of HCV notifications by the health department to the notifying general practitioner (GP) may increase treatment uptake. In this study, we explore the impact of using hepatitis C notifications systems to engage diagnosing GPs and improve patient access to treatment. METHODS AND ANALYSIS: This study is a randomised controlled trial comparing enhanced case management of HCV notifications with standard of care. The intervention includes phone calls from a department of health (DoH) specialist HCV nurse to notifying GPs and offering HCV management support. The level of support requested by the GP was graded in complexity: level 1: HCV information only; level 2: follow-up testing advice; level 3: prescription support including linkage to specialist clinicians and level 4: direct patient contact. The study population includes all GPs in Tasmania who notified HCV diagnosis to the DoH between September 2020 and December 2021. The primary outcome is proportion of HCV cases who initiate DAAs after 12 weeks of HCV notification to the health department. Secondary outcomes are proportion of HCV notifications that complete HCV RNA testing, treatment workup and treatment completion. Multiple logistic regression modelling will explore factors associated with the primary and secondary outcomes. The sample size required to detect a significant difference for the primary outcome is 85 GPs in each arm with a two-sided alpha of 0.05% and 80% power. ETHICS AND DISSEMINATION: The study was approved by University of Tasmania's Human Research Ethics Committee (Protocol ID: 18418) on 17 December 2019. Results of the project will be presented in scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04510246. TRIAL PROGRESSION: The study commenced recruitment in September 2020 and end of study expected December 2021.
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    Understanding how to live with hepatitis B: a qualitative investigation of peer advice for Chinese people living with hepatitis B in Australia
    Wallace, J ; Xiao, Y ; Howell, J ; Thompson, A ; Allard, N ; Adamson, E ; Richmond, J ; Hajarizadeh, B ; Eagle, M ; Doyle, J ; Hellard, M (BMC, 2022-03-18)
    BACKGROUND: Hepatitis B is a chronic viral infection, a leading cause of primary liver cancer and identified as a major public health priority by the World Health Organization. Despite a high proportion of people in Australia who have been diagnosed with hepatitis B, significant gaps remain in health care access and in accurate knowledge about hepatitis B. Most people with hepatitis B in Australia were born in China, where the infection has an intergenerational impact with significant social implications resulting from the infection. Understanding how people of Chinese ethnicity with hepatitis B understand and respond to hepatitis B is imperative for reducing morbidity, mortality, and the personal and social impact of the infection. METHODS: Qualitative semi-structured interviews with people with hepatitis B of Chinese ethnicity recruited through a specialist service identified the advice people with hepatitis B thought was important enough to inform the experience of people newly diagnosed with hepatitis B. A thematic analysis of the data privileged the lived experience of participants and their personal, rather than clinical, explanations of the virus. RESULTS: Hepatitis B infection had psychological and physical consequences that were informed by cultural norms, and to which people had responded to with significant behavioural change. Despite this cohort being engaged with specialist clinical services with access to the most recent, comprehensive, and expert information, much of the advice people with hepatitis B identified as important for living with hepatitis B was not based on biomedical understandings. Key suggestions from people with hepatitis B were to form sustainable clinical relationships, develop emotional resilience, make dietary changes, regulate energy, and issues related to disclosure. CONCLUSIONS: The study highlights conflicts between biomedical and public health explanations and the lived experience of hepatitis B among people of Chinese ethnicity in Australia. Beliefs about hepatitis B are embedded within cultural understandings of health that can conflict with bio-medical explanations of the infection. Acknowledging these perspectives provides for insightful communication between health services and their clients, and the development of nuanced models of care informed by the experience of people with hepatitis B.